A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Lung Cancer, Pancreatic Cancer
Trial Information
A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer
OBJECTIVES:
- Determine the antitumor activity of CI-1040 in patients with non-small cell lung,
breast, colon, or pancreatic cancer.
- Determine the safety profile of this drug in these patients.
- Assess quality of life (overall and for each tumor type) of patients treated with this
drug.
- Determine the relationship between study drug concentration and antitumor response in
these patients and target suppression and safety of this drug.
- Correlate target suppression (pERK) with antitumor effects of this drug in these
patients.
- Correlate the mRNA expression profile of the tumors with antitumor effects of this drug
in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(non-small cell lung vs breast vs colon vs pancreas).
Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 28 days during the first 6 months of
study therapy.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 52-172 patients (13-43 per stratum) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or inoperable non-small cell
lung, breast, or colon cancer or duct cell carcinoma of the exocrine pancreas
- Bidimensionally measurable lesions that are not previously irradiated
- New lesions that have developed in a previously irradiated field may be used as
measurable disease
- No brain metastases
- Patients with prior brain metastases are allowed provided they have undergone
prior resection of metastases and/or 1 prior course of cranial irradiation, have
no new sites of brain metastases since then, have no worsening CNS symptoms, and
have discontinued prior corticosteroids for at least 30 days
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST or ALT no greater than 2 times ULN (5 times ULN if due to liver involvement)
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study
participation
- Capable of swallowing intact study medication capsules
- Capable of following instructions regarding study medication or has daily caregiver
to administer study medication
- No concurrent serious infection
- No life-threatening illness unrelated to tumor
- No other prior or concurrent malignancy within the past 3 years except nonmelanoma
skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 2 weeks since prior immunotherapy or biologic therapy
Chemotherapy:
- At least 4 weeks since prior cytotoxic chemotherapy
- No more than 1 prior cytotoxic chemotherapy regimen for metastatic non-small cell
lung or colon cancer
- No more than 2 prior cytotoxic chemotherapy regimens for breast cancer
- No prior cytotoxic chemotherapy for pancreatic cancer
Endocrine therapy:
- See Disease Characteristics
- At least 2 weeks since other prior hormonal therapy
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent anticancer agents
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John J. Rinehart, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000069279
NCT ID:
NCT00033384
Start Date:
February 2002
Completion Date:
November 2003
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Lung Cancer
- Pancreatic Cancer
- stage III colon cancer
- stage IV colon cancer
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- recurrent colon cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- duct cell adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Breast Neoplasms
- Colonic Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
- Lung Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
